Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-30 @ 11:36 PM
Study NCT ID:
NCT06401603
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2024-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To find the recommended doses of lisaftoclax and olverembatinib that can be given in combination with decitabine to participants with advanced CML and Ph+ AML.
Detailed Description:
Primary Objectives
• To establish the minimum safe and biologically-effective dose of lisaftoclax and olverembatinib in combination with decitabine
Secondary Objectives
* To determine the rate of conversion to CML-CP for participants with advanced phase CML or complete remission (CR)/CR with incomplete hematology recovery (CRi) for participants with Ph+ AML, within 4 cycles of combination therapy
* To assess other efficacy endpoints (CR rate, measurable residual disease negativity by flow cytometry, rates of CCyR, MMR, MR4 and MR4.5, relapse-free survival, overall survival)
* To assess proportion of participants proceeding to allogeneic hematopoietic stem cell transplantation
* To determine the safety of the combination regimen
Exploratory Objectives
* To evaluate the impact of olverembatinib monotherapy on signaling pathways and apoptotic protein expression
* To assess relationship between baseline signaling pathway activation and apoptotic protein expression on response and long-term outcomes such as overall survival (OS) and relapse free survival (RFS).
• To establish the minimum safe and biologically-effective dose of lisaftoclax and olverembatinib in combination with decitabine
Secondary Objectives
* To determine the rate of conversion to CML-CP for participants with advanced phase CML or complete remission (CR)/CR with incomplete hematology recovery (CRi) for participants with Ph+ AML, within 4 cycles of combination therapy
* To assess other efficacy endpoints (CR rate, measurable residual disease negativity by flow cytometry, rates of CCyR, MMR, MR4 and MR4.5, relapse-free survival, overall survival)
* To assess proportion of participants proceeding to allogeneic hematopoietic stem cell transplantation
* To determine the safety of the combination regimen
Exploratory Objectives
* To evaluate the impact of olverembatinib monotherapy on signaling pathways and apoptotic protein expression
* To assess relationship between baseline signaling pathway activation and apoptotic protein expression on response and long-term outcomes such as overall survival (OS) and relapse free survival (RFS).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-03867 | OTHER | NCI-CTRP Clinical Registry | View |